(58 days)
Not Found
No
The summary describes automated analysis and quantification based on standard regions of interest and comparison with existing scans, but does not mention AI, ML, or related terms like deep learning. The analysis appears to be based on predefined algorithms and comparisons rather than learned patterns.
No
The device aids in assessment and quantification of pathologies but does not directly treat or prevent a disease; it is a diagnostic aid.
Yes
The software "aids the Clinician in the assessment and quantification of pathologies" and "aids in the assessment of human brain scans," which directly supports making a medical diagnosis.
Yes
The device is described as "Scenium display and analysis software" and its function is post-processing of PET scan data. It is deployed via medical imaging workstations, implying it runs on existing hardware and does not include its own dedicated hardware component. The description focuses solely on the software's capabilities for visualization, processing, and analysis of image data.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Scenium's Function: Scenium software analyzes PET scans, which are medical images. It processes and quantifies data derived from these images, not from biological samples taken from the patient.
- Intended Use: The intended use describes aiding clinicians in assessing and quantifying pathologies from PET scans of the human brain. This is image analysis and interpretation, not laboratory testing of biological samples.
While the software aids in diagnosis by providing quantitative information from images, it does not perform the diagnostic test itself on a biological sample. The PET scan itself is the diagnostic procedure, and Scenium is a tool for analyzing the results of that procedure.
Therefore, based on the typical definition of an IVD, Scenium does not fit the criteria. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
Product codes (comma separated list FDA assigned to the subject device)
90KPS, LLZ
Device Description
Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.
The software is post processing and does not control the scanning features of the system.
Mentions image processing
Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.
The software is post processing and does not control the scanning features of the system.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET scans
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician; medical imaging workstations
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Mirada Solutions. The word "mirada" is in bold, black letters on the top line. Below that, in smaller letters, is the word "solutions". To the right of the text is a stylized image of an eye.
Report Page 1 of 2 Type: Rev.Date: 20 November 2004 Doc.No: ms 5530 - 1 File Ref: RA Title: Scenium 510(k) summary information.
1 GENERAL INFORMATION
DEC 1 5 2004
Company and Contact Details:
| Submitters Name: | Establishment Registration Number: | ||
|---|---|---|---|
| Mirada Solutions Ltd | 3003493157 | ||
| Address: | Tel. | Fax. | |
| Level 1, 23-28 Hythe Bridge Street | 44-1865-265 500 | 44-1865-265 501 | |
| City: | State: | Post code: | Country: |
| Oxford | OXON | OX1 2ET | United Kingdom |
| Contact Name in UK: | Contact Title: | Contact E-mail Address: | |
| Michelle Sawyer | VP Quality& | ||
| Regulatory Affairs | michelle.sawyer@mirada-solutions.com | ||
| Contact Name in US: | Contact Title in US: | Contact E-Mail Address in US: | |
| Ms. Maria Ebio | Regulatory Affairs | ||
| Manager | maria.ebio@ctimi.com | ||
| Telephone Number in the US: | |||
| 865-218-2534 | Fax Number in the US: | ||
| 865-218-3019 | Contact Address in US: | ||
| 810 Innovation Drive, Knoxville, TN 37932 |
Proprietary name of Device: Scenium
Common Name of Device: Emission Computed tomography system, Product Code: 90KPS Classification: Class II: Sec. 21 CFR. 892.1200
Performance Standard: 21 CFR Subchapter H, Emission Computed tomography system Predicate Device(s):
| 510(k) No. | Trade name | Manufacturer | Component Applicable to |
|---|---|---|---|
| K041022 | NeuroQTM | Syntermed, Inc | Display and analysis program |
| K041543 | GE Discovery ST | GE Healthcare | Display and analysis program |
Reason for submission: First market clearance application for the device.
1
Image /page/1/Picture/0 description: The image shows the logo for Mirada Solutions. The word "mirada" is written in bold, black letters, with a small black circle above the "i". Below "mirada" is the word "solutions" in a smaller, lighter font. To the right of the text is a stylized graphic that appears to be an eye.
Device description:
Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.
The software is post processing and does not control the scanning features of the system.
Summary of intended uses:
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
Technological characteristics:
This software is similar in uses and applications to those of the predicate devices. Both this and the predicate devices are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from PET scans.
Safety and effectiveness concerns:
The device is designed and manufactured under Quality system regulations as outlined in 21 CFR & 820 .All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 820.1200 have been met and additionally the software is in compliance with the requirements of ISO 14971 - Medical Devices application of risk management.
Substantial equivalence:
Based upon the above considerations, Mirada believes that the Scenium software is substantially equivalent to the chosen predicate devices. The Scenium software and the predicate devices are all post-processing and provide the same features of visualization and numeric data.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Mirada Solutions Ltd. % Ms. Maria Ebio Regulatory Affairs Manager CTI Medical Imaging 810 Innovation Drive KNOXVILLE TN 37932
Re: K042863 Trade/Device Name: Scenium display and analysis software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 KPS and LLZ Dated: October 18, 2004 Received: October 18, 2004
Dear Mr. Ebio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CATION AND FOR FOR INDICATION FOR USE FORM IN
Ver/ 3 - 4/24/96
Applicant: Mirada Solutions Ltd.
| 510(k) Number (if known): | K 042863 |
|---|---|
| --------------------------- | ---------- |
Device Name: Scenium
Indications for Use:
Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescriptive Use | ✓ |
|---|---|
| ------------------ | --- |
OR
| Over – The – Counter Use | |
|---|---|
| -------------------------- | -- |
(Per 21 CFR 801.109)
(Per 21 CFR 801.109) (Optional Format 1-2-96) Truthful and Accurate Statement
David A. Ingram
(Division Sian-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number